EMA updates clinical trial data publication guidance

The European Medicines Agency (EMA) has revised its guidance on the publication of clinical data that came into effect in October of this year. The revised guidance contains a number of changes including:

• Clarification that all clinical reports submitted or cross-referenced in a regulatory application will be published following the redaction of commercially confidential information (CCI) and protected personal data (PPD).
• Information on how sponsors should manage the removal of “out of scope” individual patient data from clinical study reports
• How the agency will handle incomplete redaction proposals
• How sponsors should distinguish between redacted CCI and PPD within their documents.

Please click here for the revised guidance and here for a summary of the changes made to the previous published version.

Thus far, the EMA has published clinical data for four drugs: Armisarte (pemetrexed diacid monohydrate) and Caspofungin Accord (caspofungin acetate) published on 24th November 2016, Kyprolis (carfilzomib) and Zurampic (lesinurad) published on 20th October 2016.